`
`
`
`DEPARTMENT OF HEALTH & HUMAN SERVICES
`
`
`
`
`
`Public Health Service
`Food and Drug Administration
`Rockville, MD 20857
`
`
`
`NDA 21-196/S-007
`
`Orphan Medical, Inc
`Attention: Dayton T. Reardon, PhD, RAC
`Vice President of Regulatory Affairs
`13911 Ridgedale Drive, Suite 250
`Minnetonka, MN 55305
`
`Dear Dr. Reardon:
`
`Please refer to your supplemental new drug application dated June 28, 2005, received June 29, 2005,
`submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Xyrem (sodium
`oxybate) oral solution.
`
`We acknowledge receipt of your submission dated August 18, 2005.
`
`This supplemental new drug application provides for an amended Patient Prescription and Enrollment
`Form.
`
`We have completed our review of this application, as amended. This application is approved, effective
`on the date of this letter.
`
`The final printed labeling (FPL) must be identical to the prescription form submitted August 18, 2005.
`
`Please submit an electronic version of the FPL according to the guidance for industry titled Providing
`Regulatory Submissions in Electronic Format - NDA. Alternatively, you may submit 20 paper copies
`of the FPL as soon as it is available but no more than 30 days after it is printed. Individually mount 15
`of the copies on heavy-weight paper or similar material. For administrative purposes, designate this
`submission "FPL for approved supplement NDA 21-196/S-007.” Approval of this submission by
`FDA is not required before the labeling is used.
`
`In addition, submit three copies of the introductory promotional materials that you propose to use for
`this product. Submit all proposed materials in draft or mock-up form, not final print. Send one copy to
`this division and two copies of both the promotional materials and the package insert directly to:
`
`
`
`
`
`
`
`If you issue a letter communicating important information about this drug product (i.e., a “Dear Health
`Care Professional” letter), we request that you submit a copy of the letter to this NDA and a copy to
`the following address:
`
`Division of Drug Marketing, Advertising, and Communications, HFD-42
`Food and Drug Administration
`
`
`
`5600 Fishers Lane
`Rockville, MD 20857
`
`
`
`
`
`
`

`

`MEDWATCH, HFD-410
`FDA
`5600 Fishers Lane
`Rockville, MD 20857
`
`NDA 21-196/S-007
`Page 2
`
`
`
`
`
`
`
`
`We remind you that you must comply with reporting requirements for an approved NDA (21 CFR
`314.80 and 314.81).
`
`If you have any questions, call Courtney Calder, Pharm.D., Regulatory Project Manager, at (301) 594-
`5528.
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`Sincerely,
`
`{See appended electronic signature page}
`
`Russell Katz, MD
`Director
`Division of Neurology Products
`Office of Drug Evaluation I
`Center for Drug Evaluation and Research
`
`
`

`

`---------------------------------------------------------------------------------------------------------------------
`This is a representation of an electronic record that was signed electronically and
`this page is the manifestation of the electronic signature.
`---------------------------------------------------------------------------------------------------------------------
` /s/
`---------------------
`Russell Katz
`9/16/2005 04:11:13 PM
`
`